SN-50 Serial Syringe Pump User Manual
Contents
1. Figure 2 6 15 1 Open the fastener 28 Figure 2 6 15 2 Clamp tightly the supporting pole e Refer to the following figures for the method to fix it on the horizontal supporting pole Turn the whole fastener counterclockwise at an angle of 90 press the rotor shaft cover to open the fastener for 90 turn the handspike to clamp tightly the supporting pole Figure 2 6 15 3 Turn for 90 counterclockwise 29 Figure 2 6 15 5 Clamp tightly the supporting pole 2 7 Battery charging management 2 7 1 Battery 1 SN 50F6 Battery models 12v 2300mAh 72 51 29mm 2 SN 50C6 SN 50C6T Battery models 12v 2000mAh 72 51 29mm Out looking of NI MH battery no distortion leakage of liquid etc Discharge cut off voltage is 10V 30 Working voltage is above 12V charge and discharge time check for the chargeable battery in the pump is required at frequency of once every three months to avoid abnormal operation during use caused by battery end of life The rated discharge time of the battery is three hours Yet in case of damaged battery or fail of full charge the powering time by the battery is not guaranteed before the first time of use the battery should be continuously charged for 12 hours in power off state In case of long term idle the pump should be charged once every three months to avoid condemnation caused by automatic discharge In case of battery low timely charge or power off is required Otherwise ex2. Use SN Serial Syringe PUDO 20 AO Ai in dele 20 7020 ystemoeltescior lat 20 216 3 bodde 5 VEIDIEO A A oh le eb ae ae SE ERE 20 ZA OM RAS SELES E E OT DLE 21 2 6 Denver init Valle Setin E errada ant bats d uiua 21 2 00 Occlusion D tection Pressure MI di 22 OT SVMS Code Selecione eeu IN 22 200 BASE BES HAS A A lc 23 20 9 Delivered Volume US A T N tele Genie lle enes 23 Bon TUAL Pe OMI EPR REO Eu o Sm 23 2 5 1 Syringe CAD iia 26 2 6 12 Body Weight Mode SN 50C6T ooooooooooccccccccccccocooooooconononococonananannonononnncncncnannns 27 2 0 IS Standard RS2 32 TERRACE oido 27 2 6 14 Multi channel Ssyringe ld Neder 28 2 06 15 Device KHA HON ti 28 2 7 Battery cnarging MANAGSM lui diia 30 EMI EN E O C 30 a EE 31 3 TROUBLESHOOTING RR 33 A ug pure ce G DN 34 5 INFUSION CHARACTERS IGS in as 35 Scb NTUSIOM ACCURACY OE PUN dl e ad dc BEDE 35 DZ Properes or LIOW Tate accurate E 35 3 9 Occlusion Response Characteristics 2 ida 37 6 PRODUCT STANDARD CONFIGURATION eee eren rennen nnn nnn anna 38 T RELATED INFORMATION iota i 2o dia ac er coa ooa n iov vue s uta An re 39 1 Safety Information 1 1 Indication for User Manual In this manual the following information is used for emphasizing the related information or potential risk to patients or equipment Caution Used for indicating the possible caused damage to the equipment or environment Warning Used for indicating the pos
3. and the user can use the four setting keys to set infusion flow rate and the corresponding values will be shown on the LED display are the quick setting keys are the slow setting keys in YA pause state press and hold to quickly adjust the flow rate faster Press AN and hold to adjust the flow rate slower Setting can be performed only in standby or pause state After startup all the flow rate adjustment keys are locked 2 6 5 Delivery Limit Value Setting e Delivery limit value setting is for setting the limit value of total infusion volume 21 Select Y e In standby or pause state use key to enter delivery limit value setting state At this time indicator lights and LED displays the current limit value At this time the four setting keys can be used for adjusting the limit value for total infusion volume and the corresponding values are shown on the LED display In Select 7 startup state the datum is locked At this time after pressing key only the set limit value can be viewed Silence ES Select Y e In standby or pause state simultaneously press key and key the set limit values will be reset 2 6 6 Occlusion Detection Pressure Setting e There are three levels of occlusion detection pressure High H Center C and Low L The pump use the last set pressure level as the default after power on Select Y e n standby or pause state use key to enter occlusion detection oN pressure setting stat
4. be given again Except Battery Low alarm and Pause A Battery Exhausted alarm and System Error it is to press key to remove alarm and enter pause state The alarms happened in injection process such as Finish Occlusion Syringe Dislocated Plunger Clutch Disengaged Flow Rate Over Limit Volume Over Limit Battery Low Battery Exhausted System Error are the high level alarms The liquid is going to be finished nearly empty is middle level alarm Other alarms are low level alarms such as Non operation Time Over 2 6 11 Syringe Calibration e he unit of syringe calibration mL h mmHg or kPa e n standby or pause state pull the syringe plunger to be calibrated to the position of roughly 5mm over the rated scale line Fully filling up with water is required It is also required to be connected securely with extension tube and scalp needle for ensuring the accuracy of the calibration and are to be properly clamped on the device Purge 4d e Press and hold key to push the plunger to the rated capacity scale line Purge 4d 10mL 20mL 30mL or 50mL of the syringe Release key Silence ES e Press and hold key to enter calibration state of the syringe At this time the infusion state indicator of flashes at the same time release Silence ES key At this time the LED display shows the code of the current oN calibrated syringe on this channel on this device the user also can press S A Or to set the desired code f
5. e Incase of voice and light alarm given at interval for low battery timely charge or AC power connection to the pump is required in case of continuous voice and light alarm for battery exhausted the pump will come to an end of work Please power it off immediately It can not be used until AC power is reconnected Charge method In power off state it is to connect AC power through to the syringe pump The AC power indicator lights Then the pump is being charge Note Continuous charge for 12 hours is required in power off state e n case of long term idle the pump should be charged once every three months to avoid 34 condemnation caused by automatic discharge e After long term idle charge and discharge check for the battery is required before reuse to avoid fail of work with internal battery in case of power fail If abnormal charge and discharge of the battery found please contact the authorized service provider for changing to the new chargeable battery assembly Authorized personnel are required for changing the battery Battery change method Remove the screw of the back cover open the back cover to take down the terminal pin then screw off the screws of the battery pack to take the old battery out after placing the new battery in insert the battery terminal pin into the holder finally replace the screws and screw them down 5 Infusion Characteristics 5 1 Infusion Accuracy of Pump e The 2 accuracy of flow rate includ
6. kg xSolution volume mL x60 Drug volume mg x 1000 When the unit of dose is mg kg h Flow rate mL h Dose volume mg kg h xBody weight kg xSolution volume mL Drug volume mg 2 6 13 Standard RS232 Interface e Standard RS232 interface is equipped on the pump for bi direction communication Shield cable is required for RS232 communication The device connected to the RS232 interface is required in compliance with the requirements as per the standard 21 of IEC60950 1 2005 If needed please ask for RS232 interface protocol from Sinomdt company for further details The device connected to this device must be the designated device by Sinomdt company 2 6 14 Multi channel Syringe In case of multi channel syringe needed it is recommended to use infusion device with check valve In case of no check valve in the infusion pipeline occlusion can not be detected at the patient and medicines will be accumulated After occlusion solved the accumulated medicine will be injected into the body of patient at an unknown speed That causes danger to the patient 2 6 15 Device Fixation e By turning the fastener on back of the device it is to fix the device vertically or horizontally on the supporting pole or bed frame e Refer to the following figures for the method to fix it on the vertical supporting pole Press the cover at rotor shaft to open the fastener at an angle of 90 turn the handspike to clamp tightly the supporting pole
7. rea ica 9 14 5 BQuipment Nameplate id 10 LAA Applicable Standards ias 12 2 PRODUCTANTRODUCTION ori 12 DENIM T PES 12 PAPA Ier LC Od NE RH c cat et oases Drea na Dana ese oat ee dcop nes een 13 2 3 Workin Principle ANG App CAUON anida 13 251A WORKS PRINCIPE rio Eu ESUo Den ie 13 29 2 Interaed ON 13 229 9 FPPC AOS Unas 13 2 2 4 Intended OPA A renes bats adele Deus s A b Neu o Aqua 13 O 14 2 4 Technical Characteristics and Parameters ib 14 24 Setup tante Ol Ote dd dd cdo 14 AE CC A O ROS 14 S T KS PUSS LARC woe asic kis a a ue ate Soe anes asad asad sda RES SE REG itai iine dte SEER 14 2 4 4 Display range of volume delivered ooccccooonncnnononononoconcnonononcnnnnnnnccnnononcnnnnnnnnnnnonanoss 14 2 A SSCUING or delivers MMI AAA o O II 14 2 4 6 Occlusion detection DreSSUTE aida dete e REED pea eu equa oS 15 Z4 Story RECO iaa dais 15 A hc esa cams nace ste A oon S edt cde cit ade ae oe SETE ETT ease REDER VET REDER 15 2 4 DOW CT UO ca E O TEN 15 pe NA A A A 15 2 4 TI Overall DIMENSIONS A A oM Edu en ob d uv aute 16 A LO 16 DA AS Sy MMC ES SUD POU ere ROSE NOS eee ed Mee I vidos IRA Iud mede 16 2 COM POSO ita DINE ROME UR d 16 2 5 1 Compositions and Part Introduction of SN 50C6 System ccoooooccnccnncccnnconcncnnnnnancnnnnnos 17 2 5 2 Compositions and Part Introduction of SN 50F6 System eese 18 2 5 3 Compositions and Part Introduction of SN 50CO6T SysteM ooooccccccncccnncnnccnnnonnnccnnnnnos 19 2 0 How to
8. those over 1000mL it is 1mL 2 4 5 Setting of delivery limit 0 1mL 9999mL 0 1mL step when value is under 1000mL and for those over 1000mL it is 1mL step 14 2 4 6 Occlusion detection pressure High H 800mmHg 200mmHg 106 7kPa 26 7kPa Center C 500mmHg 100mmHg 66 7kPa 13 3kPa Low L 300MmHg 100mmHg 40 7kPa 13 3kPa 2 4 7 History Record These serial products can maximally store 1000 pieces of history records The record includes the following information flow rate alarm data total volume delivered pipeline occlusion pressure delivery limit and syringe specification 2 4 8 Alarms For a safe and reliable infusion these serial products are equipped with the following alarm functions Occlusion Nearly empty Finish Syringe dislocated Plunger Clutch disengaged Battery low Battery exhausted Power cable disconnected Flow rate over limit Volume over limit System error Non operation time over please refer to 2 5 9 for further details 2 4 9 Power Supply Power Voltage AC 110V 230V Power frequency 50 60 Hz 1Hz Battery voltage Rated DC 12V Battery capacity A fully charged battery can support a channel working at the speed of 5mL h for more than 6 hours Maximum power 30VA SN 50C6 30VA SN 50C6 40VA SN 50F6 Operating method intermittent load continuous operation Note Before the first time of use the battery mus
9. 2 Fax 0086 755 26755687 Zip code 518052 Website www sinomdt com Email info sinomdt com After service provider Sino Medical Device Technology Co Ltd Hotline 0086 400 886 0121 Fax 0086 755 26755687 Zip code 518052 Address 6th Floor No 15 Building Majialong Industrial Zone Nanshan District Shenzhen P R China Shanghai International Holding Corp GmbH Europe Add Eiffestrasse 80 20537 Hamburg Germany Tel 49 40 2513175 Fax 49 40 255726 E mail shholding hotmail com 39
10. 8uesIp y93N 193UNTJ 18 2 5 3 Compositions and Part Introduction of SN 50C6T System Figure2 5 3 sn 50C6T syringe pump qoy 2504 Kay dong Koy dwg boy HONO IT kay TAPS Aay pIeAJOJ 158 Aoy K1onb ourmgoA 630 Sy 9909 mm oydspuey oSun s jonmqoSuu g jo psuonexgjenmeqoSuu g duej asuuikg soproy oduLiAs Koy 3uryos MO S Kay durgos qomo UOT ESIDUI mod DY UOTyeorpus oAo Aeg a Koy MOJ uonespur Uoreorioods aSuLnI S uoneorpur 3727S VOTSOJUT UOTJEOTPUT Uere poseojsip oduu g Ae dstp Sumos oAo UOTyeorpur UOTyEOTDUI UOT EOTpUI UOTJEOTDUE usere k uonoejes eunsseiduomoejap uos wepe qsg Ado Aeony wwe uoin erdsip penip qu poseBuasip qojnj 1o2unjd 2 6 How to Use SN Serial Syringe Pump 2 6 1 Startup After connecting utility power AC through AC power indicator lights and then the pump is in power on state 2 6 2 System Self test for Startup After pressing power key for 1 2 seconds the system starts self test In case of no ERR displayed on the LED digital display it means a normal pump At this time the y device is in a standby state At this time if to press and hold FA key the device enters a hibernation and power saving state At this time the four bit LED digital D in turn Press any key of this channel except key to display shows the sign of D enable this channel And if press the power key for 1 2 seconds the device will GEC powe
11. SN 50 Serial Syringe Pump User Manual Version 2 6 Sino Medical Device Technology Co Ltd Statement The information contained in this user manual is based upon the experience and knowledge acquired by Sino Medical Device Technology Co Ltd hereinafter referred to as Sinomat before publishing this manual oinomdt firmly believes that the information provided with this manual is correct and reliable but no guarantee is provided for the content of the manual This user manual aims at providing guidance on use operation and maintenance of the syringe pump Therefore oinomdt shall not be responsible for any property loss or physical injury caused by citing the content of this manual for other use All copyrights reserved Duplication and dissemination of the content and information in this manual are prohibited without prior consent from Sinomat The content of the manual is subject to changes due to product upgrade or improvement without further notice Please carefully read through this user manual before installing and using the SN 50 series syringe pump Contents SAFETY INFORMA TION as 5 LA Indication tor User MAMA AA A A AA eu A 5 1 2 General Introd chomto Sd ias 5 1 5 BlectriceMechantealSaley ac corse coches cs sea dounsesat A a etat Un Idee apd rope RbE 6 1 9 Bleettic S dE ae o oia 6 1 5 2 Operatin9 Sale ti odos 7 1 4 Symbols ana La Sra litis 8 LAT Satety SyDOLS SA da 8 142 Transportation SV TDOls
12. able for the model and dimensions refer to the figure for product structure 16 2 5 1 Compositions and Part Introduction of SN 50C6 System Figure2 5 1 sn 50c6 syringe pump Jo eyidspueqosun S janmeqoSun g jopsuonexgjoneqeSun g durpooBu s opor ogundg kon Sumas Ao S Tusng Koy Zus Ye UOT ESIDUI Jomod DY Kay dos uoneorpor orgy Kane Aay dires Kay MOJ KOS preAJoj 4584 UOTjEOTDUI uoreogroeds eduri s ax Asanb ouo Teo T UOTEOTDUE 97815 UOISTJUI 93 9000 uoneopur wee de poyeoopsrp ours ejdsrp SurgosoAo uomeorur uomeorpur uoyeopur uoneorpur were Kay uonoopog amsseduonooop uorsmpooo unwpeum Adu Aeon Unepeuormpoo Aejdsp esp ATT poseBuosp uompnosunjg 2 5 2 Compositions and Part Introduction of SN 50F6 System Figure2 5 2 sn 50F6 syringe pump exrdspueq oSuri qo3nT Jeusnd key doy 493 dn els Ay PIBMIOJ 189j Aey Atenb eumToA 930 fey eoue rg key 107199795 9118q eBurl4g OTS UOTIBXIJ e Lreq eSuri g rr iL dey e8uTI G Im igi T e dsrp 3ur33es TeAe emsseJd uorj2e1ep UOTSN IA Jep oq adutIAs Qi O Oz GD D CAD ED UOT489TpUT uree ys Tura UOTFBoTPUT A3due TIBON UOT BOTPUT Wre e UOTSN I0Q AeTdsIp e1IZIp HT Aoy 3UTJ 9S MOTS A0y 3UTJ 98 N9TNY UOTJBITPUT Jemod y UOT390TpUT 949 410 Jeg Aoy IOMOJ UOTIB9TPUT uoT3eorjroeds SBUTI S UOTOIPUT 9484S UOTSNJUT UOTJVOTPUT weqe peyeooTsrp aBuTI s UOTIBITPUT WETE pe8e
13. and syringes are used the result may deviate 5 3 Occlusion Response Characteristics e Occlusion alarm time is the most important index for the occlusion response characteristics In this experiment 50mL Shandong Weigao Jierui branded syringe is used The following data are the result only by using this kind of syringe Note Occlusion alarm time is affected by the various factors including flow rate syringe manufacturing techniques syringe specification and solution quantity filled in patient pipeline length and pressure etc Occlusion Occlusion Occlusion Alarm Time Alarm Level Pressure 35 seconds 37 1 hour 15 minutes and 1 seconds 1 hour 29 minutes and 50 seconds e Bolus dose caused by occlusion alarm In this experiment Shandong WEGO Jierui 50ml syringes are used inject at the rate of 5ml h lf the alarm pressure is set as low the bolus dose is 0 06ml lf the alarm pressure is set as high the bolus dose is 0 2ml h 6 Product Standard Configuration e Syringe Pump 1 e Power cord 1 e Pump fastener 1 e User manual 1 e Certificate of conformity 1 e Warranty card 1 38 7 Related Information Manufacturer Sino Medical Device Technology Co Ltd Registration address 6th Floor No 15 Building Majialong Industrial Zone Nanshan District Shenzhen P R China Manufacturing address 6th Floor No 15 Building Majialong Industrial Zone Nanshan District Shenzhen P R China Tel 0086 755 2675569
14. arge and discharge time check for the chargeable battery in the pump is required at frequency of once every three months to avoid abnormal operation during use caused by battery end of life The rated discharge time of the battery is three hours Yet in case of damaged battery or fail of full charge the powering time by the battery is not guaranteed 32 Attention before the first time of use the battery should be continuously charged for 12 hours in power off state In case of long term idle the pump should be charged once every three months to avoid condemnation caused by automatic discharge In case of battery low timely charge or power off is required Otherwise exhaustion may cause damage to the battery Attention the useless battery should be sent the appointed place by the environment protection department or mailed to Sinomdt company for disposal to avoid environment pollution Please properly dispose the device at expiration of product life and the scrapped parts during maintenance to avoid environment pollution Attention The injection process should be monitored by medical professionals regularly 3 Troubleshooting Cause Corrective actions Unreliable flow Fail in placing the syringe barrel into Correctly re installed rate the slot in the syringe holder Unmatched syringe Select the calibrated syringe Battery Low Fail in charging the battery after the Power it off for charge alarm give
15. e At this time LED will display OCCL Press or YA to switch among H C and L 2 6 7 Syringe Code Selection Start 4 e f the syringe is not installed pressing key will cause Syringe Start 4 dislocated alarm if the syringe code is not set after pressing key the device will automatically set to the code of same syringe specification as the previous time and start infusion Select Y e n standby or pause state use key to enter syringe code setting At this time XX will be shown on the LED display XX indicates the syringe code S EN YA Press or to select the desired syringe code in the syringe 22 code list 2 6 8 Fast Feeding There are two kinds of fast feeding e The volume of fast feeding is NOT added up to the total volume Purge 4d In standby or pause state after pressing and holding key the device will perform infusion at the preset purge rate At this time the fast feeding solution volume is not added up to the total infusion volume LED display shows the fast feeding infusion flow rate of the current syringe specification after releasing Purge 4d key the LED display will be back to display the originally set flow rate e Fast feeding volume is added up the total volume When the device performs infusion at a certain and normal speed after pressing and Purge 4d holding key the fast feeding solution volume is added up to the total infusion volume At this time the dev
16. es 1 mechanical accuracy of the pump and 1 manufacturing accuracy of the syringe During supervision and test following the requirement by users or supervision organization the requirements for syringe accuracy are the size error of all the sections of the syringe used is below 1 under the system pressure of positive and negative 13 33kPa minor leakage from any connecting parts including the position between rubber plug and syringe wall is prohibited Liquid leakage occurs under positive pressure air enters the infusion system under negative pressure The syringe used in accuracy test is WEGO 50ml syringe 5 2 Properties of flow rate accuracy Testing syringe 50 ml Weigao JR brand Disposable syringe Testing methods methods specified by GB9706 27 2005 Testing result is shown as below 35 Pete SC mu xm mu nu mu uu ne nm mm m mu mmo mu me me mu mu me umo mm or OP p cow a 120 Time Fig 5 2 1 The Upcurve when the rate is 5ml h PCT flux error 96 1 10 31 11 Fig 5 2 2 Horn shape curves when the rate is 1ml h ed ee dee Jee dee Se se de I I zu a l eed eo ede ene deed a Lee bone bow lh D he pi y 4 N 120 6 Time min Fig 5 2 3 The Upcurve when the rate is 5ml h 36 IAPCT flux error 2 5 11 19 31 Fig 5 2 4 Horn shape curves when the rate is 5ml h Caution Above test result is by using WEGO syringe recommended by the manufacturer If other br
17. es to the set pressure value occlusion alarm starts up e Syringe Dislocated During normal infusion if the syringe clamp is not pressed on the syringe properly the pump will give voice alarm at interval with flashing indicator and stop working e Plunger Clutch Disengaged If the push plate of the syringe is not locked between the push head and clutch or the clutch is not closed the pump will give voice alarm at interval with flashing E indicator after starting up the infusion The device can not enter infusion state During normal infusion if to press down the push head the clutch will open Then the pump will give voice alarm at interval with flashing 4 indicator and stop working e Flow Rate Over Limit If the set speed is over the range of flow rate of 10mL 20mL and 30mL pressing Start 4 key can not start up the pump The LED display will show the flow rate setting value of 10CC 20CC and 30CC respectively in turn and it gives voice alarm at interval e Volume Over Limit 24 When the solution amount of the pump reaches to the set limit value the pump will give voice alarm at interval At this time the pump stops working the speed value and limit value will be shown on the LED display alternately The limit value is displayed with voice alarm e Power Cable Disconnected After switching power on if AC power supply is not connected through or poor contact of power cord occurs during using OT indicator
18. flashes All the three block flash the pump will give voice alarm at interval e Battery Low In case of low battery 8 8 uj indicator flashes One block flashes the pump will give voice alarm at interval At this time the pump is still able to work for about 30 minutes at the flow rate of 5mL h e Battery Exhausted When the battery electricity is totally exhausted the pump will stop working E 8 uj indicator flashes All the three block flash the pump will give voice alarm at interval e System Error Mis operation may cause program error At this time ERR will be shown on the LED D digital display with voice light alarm at interval After pressing key to power off the device for restart if it is still with system error alarm please contact the authorized service provider in your region or Sinomdt company e Non operation Time Over In status of power on in case of no any operation for more than 2 minutes the pump Pause A will give interval voice alarm and show NOOP at LED then press key Silence ES to enter sleeping mode or press key to remove this alarm If continually Silence ES occur this alarm after the second time press key the pump will show NOOP but without voice e Silence Except the Battery Exhausted alarm and System Error alarm all the other alarms can Silence ES be mute by pressing key In case of no operation for longer than 2 25 minutes after mute the voice alarm will
19. haustion may cause damage to the battery the useless battery should be sent the appointed place by the environment protection department or mailed to Sinomdt company for disposal to avoid environment pollution 2 7 2 Charge This device needs to be charged in power off status the charging needs at least 12 hours which will stop automatically when the battery is full When charging first it s constant current when the battery is going to be full change to trickle charge when it s full stop charging Attention Warning after long term of use in case of the recess of the membrane please notify the manufacturer to change Otherwise mis triggering may be caused Warning because the recessed plastic lamination of keys after long term of use will possibly cause mis triggering after completing pressing the fast forward key it is recommended to carefully check if the speed goes back to the originally set value If it is the same as the fast forward speed it is required to power off Otherwise the pump will keep an infusion at purge rate That causes danger to patients At this time please notify the authorized maintenance personnel for change the key lamination Warning in case a broken clutch on the push head please change it timely Otherwise siphon will be caused making the residual solution automatically flow into the body of the patients Excessive medicine infusion will cause harm to the patients 31 Warn
20. ice dynamically adds up the output of the pump in case of total volume measurement is below 1000mL it is to increase by unit of 0 1mL after the total accumulated volume reaches 1000mL it is increase by unit of 1mL 2 6 9 Delivered Volume Query e n any state it is able to check the total infusion volume of solution into the patients Delivery 97 body by pressing key Delivery gt Silence ZX e In any state it is able to press key and key to reset the total infusion volume 2 6 10 Alarm Prompt e Nearly Empty When the residual amount of solution reaches to 1 5mm 0 8mm the Nearly Empty indicator on the panel flashes and gives voice alarm with interval at the same time e Finish 23 When the solution in the syringe is almost finished indicator flashes with voice alarm at interval and the LED digital display shows KVO flow rate of 0 5mL h At this time the pump enters KVO infusion mode e Occlusion In case of unsmooth infusion caused by occlusion needle or bended pipeline when the liquid pipeline system reaches to the set threshold value the Occlusion indicator on the panel flashes with voice alarm at interval At this time pressing Silence ES key the alarm will be mute Note There is a course from being entirely occlusion to alarm given for the occlusion alarm of the syringe by most of manufactures Along with the rise of pump output the system pressure increases When the system pressure reach
21. ing the syringe barrel must be placed into the fixation slot Otherwise infusion without medicine or large amount medicine infusion by siphon will cause harm to the patients Warning it is a must to use the syringes with the specification and model accurately calibrated by the device Otherwise unreliable infusion speed and incomplete infusion may occur For the designated syringes we recognize only their overall dimensions and structure Their biochemical physical and measuring indexes must be tested and approved by the related supervision authorities Warning while moving the syringe pump it is required to pay attention to the connection of syringe extension tube and needle to avoid harm against the patients caused by poor contact of the connectors Warning clamping installation following the requirements as shown in the figure or automatic sure fixation is required for the pump lt is prohibited to place it on a flat board without railing by bed This is to prevent the pump from falling by pulling the pipeline and causing danger to the patients Warning operation of the pump by unauthorized personnel is prohibited to avoid danger caused to the patients Attention for testing the speed of the pump it is required to use the selected syringe Attention accuracy tolerance of the syringe may decrease the precision of pump output For testing pump precision it is required to choose the high accuracy syringe Attention ch
22. ion is required before starting cleaning Cleaning methods clean the device surface with a soft brush or a piece of soft cloth clean the connector or panel edge with a brush or a piece of cloth soaked in neutral cleanser cold disinfectant or 70 alcohol or isopropyl alcohol Prevent the cleanser or disinfectant from coming into the device Pay more attention to the connector and panel edge 1 3 2 Operating Safety Warning It is required to operate the device in the specified environment Otherwise abnormal operation to the device will be caused Specified working conditions Working temperature 5 40 C Relative humidity 2096 8096 Atmospheric pressure 86kPa 106kPa Power AC 110 230V 50 60Hz 1 Hz Max power 30VA SN 50C6 30VA SN 50C6T 40VA SN 50F6 Warning It is not suitable to be operated in an environment with oxygen gas and containing flammable anesthetic of nitrogen oxide Otherwise there is the risk of explosion Warning Using improper or non calibrated syringe probably cause inaccurate speed or injection amount Warning It is required to prevent air from entering human body during using this device Warning Do not use this device in the situation with high pressure oxygen cabin or MR testing environment Caution Keep the environment clean avoid vibration keep it away from corrosive medicines dust and environment with high temperature and humidity Cautio
23. is installed on to the device the identification system will automatically adjust ready the proper flow rate up limit At this time as long as to set ready the desired injection speed and press the startup key the device will start operation 2 3 2 Intended use The syringe pumps are used for injecting drugs into human body with accurate volume stable and flow rate long time and constant injection 2 3 3 Applicable user Used for drug injection for adult paediatric and neonate for infusion theraphy 2 3 4 Intended operator The doctor nurse or well trained and qualified professional medical care personnel in the 13 hospital 2 3 5 Taboo Taboo drugs Insulin is not suitable for syringe pump 2 4 Technical Characteristics and Parameters 2 4 1 Setting range of flow rate 50mL syringe 0 1 1500mL h 0 1mL h per step when rate is under 1000mL h and 1mL h per step since 1000mL h 30mL syringe 0 1 900 0mL h 0 1mL h step 20mL syringe 0 1 600 0mL h 0 1mL h step 10mL syringe 0 1 400 0mL h 0 1mL h step Measurement unit of calibrating measurement equipment ml h 2 4 2 Accuracy Accuracy of flow rate within 2 the accuracy of syringe should be within 1 Mechanical accuracy within 1 2 4 3 Purge rate 50mL syringe 1500mL h 30mL syringe 900 0mL h 20mL syringe 600 0mL h 10mL syringe 400 0mL h 2 4 4 Display range of volume delivered 0 1 9999mL For 0 1 999 9mL the display resolution is 0 1mL and for
24. n Electromagnetic interference Make sure to keep the operation environment of the device free from strong electromagnetic interference e g the interference caused by telegraphy machine and mobile phone Caution This device is not suitable for the injection of the following medical solution Insulin Chemotherapy drugs Reminding When RS232 port not in use should be covered with protective cover Caution The syringes used must be disposable and have SFDA registration certificate in China or CE certificate in Europe it s forbidden to re use them After use the disposable syringe should be treated as medical waste by operator Caution Power line and battery provided by SinoMDT should be used otherwise the device will not work properly 1 4 Symbols and Labels 1 4 1 Safety Symbols Please read user manual before use On Off or power on Functional grounding Protective grounding Battery level European authorized representative CE certification mark The digital code of the mark is the code of the certification institution Sinomdt s logo Water proof level 4 protected against splashed water stay jl 100000011 2 O O harmless from splashed water at any angle Storage humidity Do not expose the product in the environment at humidity beyond the specified value The air pressure can t be more than 106KPa or less than 50KPa during transportation Tempera
25. n previous use or extremely long time soon idle after charge startup Improper use of the internal battery Change the battery damaged battery 33 Back streaming Fail in removing mechanical gap by Make sure that there is no air in the of blood at pressing the fast forward key before infusion pipe then push the blood back beginning of introducing the needle into vein to the vein by pressing the fast forward infusion key Fail in placing the syringe barrel into Correctly install the syringe again the fixation slot of the syringe Unsmooth Stuck handspike of the pump by Remove the solution with alcohol moving of the solution push head Generally the product redoubled with failure within the warranty period should be sent to the authorized service provider for maintenance In case of serious damage caused by misuse the maintenance will be charged at the reasonable cost Battery is beyond the scope of warranty 4 Maintenance e lf replacement of fuse needed it is to open the fuse holder at back of the pump remove the fuse cover and place the new fuse on The fuse required is the quick miniature fuse links at specification of 2A 250V 05x20 e The pump is required to make regular cleaning Use a piece of clean cloth soaked with proper amount cleanser to clean its surface and then use a piece of clean wet cloth to wipe its surface Finally dry it with a piece of dry cloth and place it on a clean rack
26. o Medical Device Technology Co Ltd Add 6th Floor Building 15 O neusty Zone Nanshan District Shenzhen P R China c ner Shanghai International Holding Corp GmbH Europe 0123 Add Eiffestrasse 80 20537 Hamburg Germany 11 1 4 4 Applicable Standards List ISO 14971 2007 ps devices Application of risk management to medical EN 980 2008 Graphical symbols for use in the labelling of medical devices EN 1041 2008 Information supplied by the manufacturer with medical devices EN 60601 1 1995 A1 A2 Medical electrical equipment General requirements for safety Medical electrical equipment General requirements for safety EN 60601 1 2 2007 Collateral standard Electromagnetic compatibility Requirements and tests Medical electrical equipment Part 1 4 General requirements for EN 60601 1 4 1996 safety Collateral standard Programmable electrical medical systems Medical electrical equipment Part 2 24 Particular requirements for EN 60601 2 24 1998 the safety of infusion pumps and controllers 2 Product Introduction 2 1 Provisions SN 50 serial syringe pumps are the volumetric injection pumps with multi channel and multi speed control The product features high precision of timing stable flow rate and less quantity of liquid required The products are particularly suitable for emergent delivering the key medicines like sodium nitroprusside dopamine isopropyl alcohol and anti bacteria medicines SN 50
27. or the calibrated syringe Start 4 e After pressing key the syringe starts automatic calibration During the automatic calibration process to avoid calibration fail please do not operate the device 26 e When the plunger is pushed to the end the device beeps at interval and automatically comes to pause state Then calibration is completed 2 6 12 Body Weight Mode SN 50C6T e Press power switch button on then press Body weight Mode button to enable body weight mode and the body weight mode screen lights on e Use Select 2 button quick setting keys C and slow setting keys ut MAN to enter dose patient body weight drug volume and solution volume the left LED screen will display final infusion rate automatically e The default dose unit is ug kg min press Select 2 button for 2 seconds the unit will turn to mg kg h e Press Start to run infusion program the back light of body weight mode screen will automatically turn off after 2 minutes when needed press Body weight on off button to turn on the back light of body weight mode screen again e In body weight mode any modification of flow rate has to through dose body weight drug volume and solution volume to calculate automatically e All setting keys are locked and can not be tuned when the infusion program is starting Note Calculation Formula of flow rate When the unit of dose is g kg min Flow rate mL h Dose volume ug kg min xBody weight
28. r off In injection status first need to press 04 key to stop injection D then press key to power off The data saved in the storage chip will not get lost after power off 2 6 3 Loading Syringe j n nr F E il y E j L fi Ini lig F UR fa e After filling up the syringe with solution and expelling air out then put the syringe into the syringe holder Warning AN Before installing the syringe it is required to expel air out of the syringe to avoid air embolism 20 Caution The barrel of the syringe is required to be inserted into the injection pump barrel fixation slot Fix the syringe barrel securely with the syringe clamp hold tightly the pusher to make the clutch open move the pusher to the end of the syringe handspike loosen the pusher to release the Clutch and to lock the syringe push plate between the pusher and the Clutch Press and hold the Fast Forward key and do not release it until solution coming out from the needle tip After setting all the parameters ready introduce the needle into vein artery of the Start lt patients and then press key Thus the pump starts infusion Warning Before infusion it is required to expel air thoroughly out from the injection connecting pipe to avoid harm against the patient caused by air embolism 2 6 4 Flow Rate Setting After power on the pump use the last set flow rate as the default flow rate
29. serial syringe pumps use 10mL 20mL 30mL or 50mL disposal sterile syringes hereinafter collectively referred to as syringe calibrated by the device In case of clamping the syringe on to the device the device will automatically identify the specification of the syringe clamped In addition the device is equipped with multi alarming functions for achieving a safe and reliable injection The products are for control on delivery volume and flow rate during clinical solution injection medicine liquid 12 nutrition liquid and blood into the body of patients 2 2 Model Coding SN 50 ooo D Model identification Product serial identification Company s code The serial products include the following models SN 50C6 SN 50F6 SN 50C6T 2 3 Working Principle and application 2 3 1 Working Principle This is a volumetric pump different from the constant pressure pump e g peristaltic pump The output of solution within a certain period will not be affected by the resistance in the infusion channel When the pressure reaches a certain value the occlusion alarming system equipped on the pump will give sound light alarm and stop running meaning that the actual output volume complies with the preset output volume The device is equipped with a micro feeding system In virtue of the circuit this system can obtain a larger speed adjustment range Once any of the four kinds of syringe with specification of 10mL 20mL 30mL or 50mL
30. sible caused injury or death Attention Used for emphasizing the important instructions These instructions relates to how to use the manual and the product or providing the additional information like detailed explanations prompt or reminding 1 2 General Introduction to Safety According to the electric safety classification this is a Class I CF type non portable equipment with internal power supply The pump is a splash proof device at IPX4 class Syringe The users are required to use the syringe meeting national standards with medical admittance license The default is Shandong Weigao Jierui branded syringe at specification of 10mL 20mL 30mL and 50mL The user defined syringe can also be used through Automatic syringe calibration function please see 2 6 11 in the Manual The followings are the brief introduction to safety precautions Operators are required never to open the casing of the device Never to cause malfunction or short circuit to the safety parts in the built in device Even in case of abnormal operation of the device unauthorized maintenance is prohibited lt is required to immediately contact the qualified and authorized personnel from Sinomat The authorized maintenance personnel can ask for the corresponding data from our company including circuit diagram and parts list etc There are no components required for maintenance inside the device It is required to follow all the warnings and cau
31. t be charged for minimum 12 hours 2 4 10 Environment Working conditions Temperature 5 40 C Humidity 2096 8096 Conditions for transportation and storage 15 Temperature 20 455 C Humidity lt 95 2 4 11 Overall Dimensions Syringe pump SN 50F6 354mm W x 190mm H x 128mm Dual channel Syringe pump SN 50C6 306mm W x 135mm H x 127mm Single channel channel uM channel with Syringe pump SN 50C6T 306mm W x 135mm H x 127mm body weight mode 2 4 12 Net Weight SN 50F6 3 5kg including clamp SN 50C6 2 3kg including clamp SN 50C6T 2 3kg including clamp 2 4 13 Syringes support syringes including models of 10ml 20ml 30ml 50ml from up to 12 different manufacturers can be stored in this device Each trademark of manufacturer is distinguished by numbers of 01 02 11 12 in which 01 represents the syringe with the trademark of WEGO what is recommended and set with 01 as default Syringes of the other numbers XX can be used by the only way of recording parameters of 10ml 20ml 30ml and 50ml model from user choose after XX through calibrating function Warning If the user defined syringe is not calibrated it may cause inaccurate injection The syringe used must be CE certified or has local market entry permit 2 5 Compositions SN 50 serial syringe pump is composed of the casing syringe clamp control plate and pusher Refer to the t
32. tions no matter they are specified or implied Q itis required to follow all the instructions on safety label 1 3 Electric Mechanical Safety The maintenance personnel who have passed the training held by Sinomat are required to open the casing change battery and mechanical parts Otherwise safety problems of the device may be caused The followings are the brief instruction to the warning information 1 3 1 Electric Safety Warning Risk of electric shock For protecting patients and medical staff secure grounding for the device and power supply socket is required Connecting 2 pin plug to the 3 core cable is prohibited Warning Risk of electric shock It is prohibited to open the casing of the device during operation or with power connection The authorized technicians are required to open the casing Caution Before using the customers are required to check if there is obvious damage on the device and cables those possibly cause danger to patients or lower performance of the device It is recommended to make regular check at frequency of once a week or more In case of obvious damage found it is recommended to change the damaged parts before using Caution Regular safety test is required for the device including leakage current test and insulation test It is recommended to the test it at frequency of once a year or to follow the requirements as per regulation and test specification Caution Power disconnect
33. ture Do not expose the product in the environment at temperature beyond the specified value Direction with this side up SINO MEDICAL DEVICE TECHNOLOGY CO LTD www sinomdt com Product Name Syringe Pump Voltage AC 110V 230V Product Model SN 50C6 Power Frequency 50Hz 60Hz Safety Class Class I 9 IPX4 Rated Power 30VA m Sino Medical Device Technology Co Ltd Add 6th Floor Building 15 Majialong Industry Zone Nanshan District Shenzhen P R China Tec rer Shanghai International Holding Corp GmbH Europe C 0123 Add Eiffestrasse 80 20537 Hamburg Germany 10 SINO MEDICAL DEVICE TECHNOLOGY CO LTD www sinomdt com Product Name Syringe Pump Voltage AC110V 230V Product Model SN 50C6T Power Frequency 50Hz 60Hz Safety Class Class I 9 IPX4 Rated Power 30VA ed E o z o U d Sino Medical Device Technology Co Ltd Add 6th Floor Building 15 Vejaong NCUSTYy Zone Nanshan District Shenzhen P R China Shanghai International Holding Corp GmbH Europe C c ner Add Eiffestrasse 80 20537 Hamburg Germany o Tes RQ pm SINO MEDICAL DEVICE TECHNOLOGY CO LTD www sinomdt com Product Name Syringe Pump Voltage AC110V 230V Product Model SN 50F6 Power Frequency 50Hz 60Hz Safety Class Class I 9 IPX4 Rated Power 40VA ed AH sx Sin
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